Surgical tube



Dec. 3, 1963 w. E. coLBURN 3,112,748

SURGICAL TUBE 2 Sheets-Sheet 1 Filed April 4, 1960 3 i I s 39 r l l Dec. 3, 1963 w. E. coLBURN 3,112,743

SURGICAL TUBE Filed Aprrl 4, 1960 2 Sheets-Sheet 2 FIG. 8.

FIG. .9.

Unite States hcc 3,li2,74 SURGCAL 'ilUfeE William E. Colburn, San Marino, Calif., assigner to Fharnaaseal Laboratories, Glendale, Calif., a corporation of California Filed Api'. 4, 1%0, Ser. No. 1,818 12 Clms. (Ci. t28-356) r This invention relates to a surgical tube, and particularly to an inexpensive, double-lumen tube having a -retention balloon.

Double-lumen surgical tubes, such as balloon catheters, are usually made of rubber. Such tubes are complicated and expensive to make and therefore usually are used several times. lt is desirable to have a less expensive tube Which can be discarded after a single use.

Rubber surgical tubes also have certain inherent disadvantages. For example, the tubes are opaque so that materials draining through the tube cannot be observed. The Wall of the tube must be relatively thick so that the tube will not collapse. This makes the usable passage small for a given outside diameter. Rubber tubes are undesirably alleeted by lubricants and by chemicals, such as sullides, present in certain body passages. The ingradients of the rubber tube may also irritate the delicate mucosa of body passages, producing secretions which tend to crust on the tube. These problems are particularly serious because the tubes are usually left in the body passage for a period of five to seven days.

Attempts to make plastic balloon catheters have not been successful because of the poor elasticity and resilience of the plastic. Lttempts to provide plastic catheters with resilient rubber balloons have also been unsuccessful because of ythe diiilculty of attaching the rubber balloon to the plastic catheter and because of rough edges at the ends of the balloon. Over-irilation, to be sure the tube is retained, aggravates the problem.

Other problems `arise in providing the proximal end of a surgical tube with a suitable connector. Those now available are expensive to make and inconvenient to use. Resealing plugs provided in the inflation arm often leak. Moreover they require use of a hypodermic needle for ination of the balloon, and lthe needle is apt Ito pierce the wall of the inflation arm rendering the tube useless and perhaps injuring the operator.

lt is `therefore an object of this invention to provide an inexpensive, surgical tube having a retention balloon.

A further object of the invention is to provide an im* lproved surgical .tube having an extruded plastic body und an inilatable rubber balloon.

A further object of the invention is to provide an effective method lfor yattaching a rubber balloon to a doubleluinen, plastic, surgical tube.

A fur-ther object is to provide a surgical tube having an improved connector at its proximal end.

A still further object of the invention is to provide a surgical tube having an improved, self-sealing plug in the inllation lumen.

The surgical tube of the present invention will be more fully understood from the description of the preferred form of the invention given with the accompanying drawings, in which:

FGURE l is an elevation of the invention;

FIGURE 2 is an enlarged sectional view on the line 2 2 of FlGURE l;

'FlGURE 3 is an elevation of the distal end of the tube, showing the balloon le inflated;

FGURE 4 is an enlarged sectional view on the line 4 1!- of FIGURE 3;

FIGURE 5 is an enlarged sectional View showing the Vinanulacturing step of shaping the tube body lil;

FGURE 6 is an enlarged sectional view on the line 6 6 of FIGURE 1;

FGURE 7 is `an enlarged View of a portion of FIG- URE 6, showing additional details;

lFIGURE 8 is a side elevation partly in section of the connector ldand the tubes associated therewith;

FIGURE 9 is a sectional view on the line 9 9 of FIG- URE 8, showing the connector 14, Without the tubes l1 and 42.

Referring now to the drawings, the surgical tube, generally indicated as lil, has an elongated tub ar body il. Body il is preferably rnade of a length of extruded plastic or rubber tubing. In most cases, plastic will be preferred for .the reasons previously mentioned. Polyvinyl chloride is a particularly suitable material, but polyethylene, polyvinyl acetate, and other nontoxic, nonirritating, flexible thermoplastics may be used. It desired, from 2O -to 50% barium sulfate can be incorporated in the polyvinyl chloride to increase the opacity of the tubing to X-rays.

The outer surface of tubular body 11 is cylindrical, while the inner surface defines a drainage channel 12 having a crescent-shaped cross .section and a relatively small inflation channel i3 having -a circular cross section. The proximal end of body lil is provided with a connector ill. The distal end of body ll is provided with a closed, rounded tip l5. A balloon lo is attached to body lil inwardly rfrom tip 15. A radial passage )t7 opens from inliation channel 13 into balloon 16. Drainage openings 43 and l@ are located between distal tip 15 Iand balloon le and commtuiicate with drainage channel l2.

As shown in FGURES 5 and `6, 'body dl is Shaped to receive the balloon i6. This is accomplished by placing a length of extruded tubing in a mold 21 and fastening the ymold together with clamping ring 22. One end of channels i2 yand i3 is then plugged and `air pressure is applied to the opposite end. The mold is then placed by holder 23 in coil 2d of an induction heater. Electric current passing through coil 24 heats mold 21. The combination of heat and internal pressure causes body 1l to defonm outwardly against the frusto-conical mold section 25, 26. Proper regulation of temperature and pressure assure adequate forming of body ll without the formation of excessive hash. For example, temperatures above the softening point of the plastic, but below the melting point and air pressures of about 30 pounds gauge pressure may be used. The cylindrical mold section 27 supports the central pontion of the tube and prevents distortion of the tube between mold section 25 and 26.

After shaping of body 1l, drainage openings 18, i9 are punched and the distal end 15 molded to form a smooth, round, closed end.

As shown in FIGURES 6 and 7, the section of body l thus fonmed has a relatively uniform wall thickness. The Wall of body 'lll llares outwardly along the frusto-conical sections 3l, 32 to form the shoulders 33, 3d. The inner surface of body il also ilares outwardly along the curved lwall surface 38, 39, ri'he cylindrical section 35 is located between shoulder 33, and shoulder 34 and preferably has the same diameter as the original extruded tubing.

Balloon le is attached concentrically around cylindrical `section 3S. he balloon is preferably formed of a length of surgical grade rubber tubing having a thickness of 0.011() to 0.020 inch. Such tubings are usually made by dipping forms in suitable solutions of compounded rubber latex and are of the type commonly known in the trade as Penrose tubing. The inside diameter of the rubber tubing should be from to 95% of the outside diame-ter of cylindrical section 35 so that the balloon is in a slio tly stretched condition. If the tubing is too large, the ends of the balloon tend to flare outwardly. lf

anar/as the tubing is too small, the stress developed will accelerate deterioration of the thin balloon. For example, highly satisfactory tubes have been made from Penrose tubing having an inside diameter of 0.250 inch and a thickness of 0.015 inch and plastic tubes having an outside diameter of 0.300 inch.

The length of balloon lo should be slightly less than the length of cylindrical section 35 so as to provide a small space between each shoulder 33, 3e and the adjacent end of balloon le: For example, the balloon may be approximately 1/16 inch shorter than cylindrical section 35 so that 1&2 inch space is left on each end.

To attach balloon lo, it is rst positioned around cylindrical section 35. The ends of the balloon 16 are then rolled back and a very thin layer 36 of adhesive is applied around each end of :cylindrical section 35. The ends of balloon 16 are then unrolied and pressed into adhesive layer 35. This pressure displaces a portion of the adhesive -into the spaces between the res ective ends of the balloon le and the radial surface of shoulders 33 and 34.

rihe adhesive selected for layer 35 must form a strong permanent bond between the rubber and vinyl materials. it should have particularly high tensile strength, be relatively resistant to deterioration by moisture, and be Without deteriorating effect on plastic body ll or balloon lo. rfhe cyanoacrylate type of adhesives described in US. Patent 2,794,788, issued .lune 4, i957, are particularly suitable.

An annular band 37 of a second adhesive material is placed over the outer surface of shoulders 33, 34, the respective ends of balloon le and the spaces between the shoulders and the balloon ends. The second adhesive material should be fairly exible, nontoxic, nonirritating to the linings of delicate body passages, and free from deleterious effects on plastic body 1l or rubber balloon 16. Suficient adhesive should be used to till any void between the respective ends of balloon lo and shoulders 33, 34 and to provide a smooth surface over the juncture of said ends with the shoulders.

Connector i4 has a tubular body itl molded of rigid polyvinyl chloride or similar plastic material. The prox- Y imal end il of body d@ is adapted to receive an extension tube 42. The other end 43 of body 46 has a tapered lead-in section 44 and is adapted to receive the proximal end of body 1l. A small, tapered tube 45 extends outwardly beyond lead-in section 44E. and is adapted to tit snugly within the in llation channel i3. A passage 46 connects tube 4S to reservoir 47. Above reservoir 47 the walls of connector 14 flare outwardly to form a cup 48. A rubber plug 49, slightly larger than cup 48, is deformed radially inwardly by the walls of cup 48 and is held in said cup by retaining ring 50. On the outer surface, the Walls or reservoir i7 are provided with flanges 51, 52 on which ejector pins impinge to drive the part out of its mold.

in use, the distal end of my surgical tube is iirst inserted through the appropriate body passage. A hypodermic needle 55 attached to a syringe (not shown) is then inserted through rubber plug 49 into reservoir 47 and the desired amount of liquid injected to inflate balloon 16. The rigid walls of reservoir 45 prevent needle 55 from damaging the tube or injuring the operator. After infiation, needle 55 is withdrawn, and Irubber plug 99 reseals. Extension tube 42 is then inserted in the open end 41 of connector lll and drainage commenced. Since the wall thickness of body ll is relatively uniform, the drainage 'channel 13 under ballon 16 is not collapsed or restricted thus allowing fluid, clots, and mucous to pass freely through channel l2. Shoulders 33, 34 and adhesive 35 block any tendency of balloon 16 to slide longitudinally along body To remove the surgical tube, rubber disc 49 lis again pierced with needle S and the iiuid withdrawn from reservoir 47, thus deiiating balloon le. Because of its elasticity,

d balloon 16 contracts tightly around tube section 35 and the surgical tube may be easily withdrawn.

While l have described the preferred form of the invention, it should be understood that those skilled in the art may make various changes in its lconstruction without departing from the spirit of the invention.

claim:

l. A surgical tube comprising: an elongated, tubular body of flexible, extruded plastic; a drainagev channel and an inflation channel defined by the Walls of said body; a tapered, frusto-conical section flaring outwardly toward one end of the body; a second frusto-conical section between said first section and the end of the body, said second section flaring outwardly away from the end of the body; a relatively short cylindrical section between the two frusto-conical sections, the diameter and wall thickness of said cylindrical sections being substantially the same as that of the major portion of the body; an annular shoulder at each end of the cylindrical section projecting radially outward to meet the base of the respective frusto-conical section; and a thin, resilient, cylindrical, elastic balloon telescoped over said cylindrical section.

2. A surgical tube comprising: an elongated cylindrical body having a crescent-shaped drainage channel and a cylindrical ination channel; a rigid connector on one end of said body; a cylindrical portion on said connector telcscoped over one end of the body and attached thereto; a relatively small, substantially cylindrical tube within the cylindrical portion and parallel thereto, telescoping into the inflation channel; a lateral extension of the connector defining a reservoir connected to said tube; an enlarged, cup-shaped connector section projecting from said extension; and a rubber plug in the cup-shaped section, said plug being deformed radially inward by the walls of said section.

3. A surgical tube comprising: an elongated, tubular body, the major portion of which has a uniform cylindrical outer surface, said body having a proxirnal end, a distal end, a drainage channel and an inflation channel; a cylindrical section near the distal end of said body, said section having an outside diameter and a wall thickness substantially equal to those of the major portion of the tubular body; an outwardly projecting, annular shoulder at each end of the cylindrical section; tapered body sections aring outwardly from the uniform cylindrical outer surface to each of said shoulders; and a resilient, elastic balloon telescoped over said cylindrical section, said balloon in its unstretched condition having an inside diameter of from 75 to 95% of the outside diameter of the cylindrical section.

4. A surgical tube as set forth in claim 3 wherein a portion of the body forming the drainage channel flares outwardly adjacent the annular shoulders to provide an enlarged drainage channel section and to maintain a relatively uniform thickness throughout the body Wall.

5. A surgical tube as set forth in claim 3 wherein the drainage and inflation channels extend from the proximal end of the body to the distal end; and the distal end of the body has a closed rounded tip, portions of which seal the distal ends of the drainage and inflation channels.

6. A surgical tube as set forth in claim 3 wherein the balloon is formed of a length of thin-walled rubber tubing having a substantially uniform thickness and diameter, and a length less than the length of the cylindrical section, the inner surface of said balloon when uninflated fitting tightly around the cylindrical body section in contact therewith; an annular space at each end of the cylindrical section, said space being defined by a portion of the cylindrical section, the adjacent balloon end, and the adjacent shoulder; and an adhesive filling said space.

7. A surgical tube as set forth in claim 6 wherein a first adhesive attaches the balloon to each end of the cylindrical surface and to the radial surface of the shoulder and a second adhesive covers the outer surface of each balloon end, the end of each tapered section and the space between each balloon end and the adjacent tapered section.

8. A surgical tube comprising: an elongated cylindrical body having a drainage channel and an inflation channel; a rigid connector on one end of said body; a portion or said connector telescoped with one end oi' the body and attached thereto; a relatively small, substantially cylindrical tube within said connector portion telescoping into the inflation channel; a lateral extension of the connector dening a reservoir communicating with said tube; an enlarged, cup-shaped connector section projecting from said extension; and a rubber plug in the cupshaped section.

9. A connector for a flexible, surgical tube having an iniiation channel and being capable of being punctured by a hypodermic needle comprising: a body having walls suciently rigid to resist puncture by the point of a hypodermic needle; a portion on said body adapted to receive one end of a surgical tube; a relatively small tube adapted to telescope into the inllation channel of a surgical tube; a reservoir, open on one outer side and defined and surrounded on the other sides by the rigid body walls; passage means in one of the rigid Walls connecting the reservoir with the small tube; and a self-sealing plug capable of being punctured by a hypodermic needle closing the open side of the reservoir.

10. A surgical tube comprising: an elongated, soft, flexible, tubular body capable of being inserted in a delicate body passage and having a drainage channel and an ination channel, said tubular body being easily puncturable by the point of a hypodermic needle; a separately formed connector rrnly attached to one end of said body, and having walls formed of a hard rigid plastic material which cannot be punctured by the point of a hypodermic needle; a reservoir, open on one side and dened and surrounded on the other sides by the rigid, puncture-proof walls of the connector; a passage dened by one of the connector walls and connecting the reservoir with the inflation channel; and a self-sealing plug capable of being punctured by a hypodermic needle closing the open side of the reservoir.

11. A. surgical tube as set forth in claim 10 wherein the walls forming the open side of the reservoir are cupsbaped; the plug is formed o a self-sealing, deformable, rubber material and has an outer diameter larger than the inside diameter of the rigid, cup-shaped walls, whereby said plug is deformed radially inwardly by said walls.

l2. A surgical tube comprising: an elongated, flexible, tubular body, capable of being punctured by a hypodermic needle and having a drainage and an ination channel; a separately formed connector rmly attached to one end or' said body, and having walls sufciently rigid to resist puncture by the point of a hypodermic needle; a reservoir, open on one side and defined and surrounded on the other sides by the rigid, puncture-resistant walls of the connector; a passage defined by one of the connector walls and connecting the reservoir with the inflation channel; a self-sealing plug capable of being punctured by a hypodermic needle closing the open side of the reservoir; and a tapered tube projecting longitudinally from the connector and telescoping into the ination channel connecting it with the reservoir.

References Cited in the le of this patent UNITED STATES PATENTS 2,043,630 Raiche lune 9, 1936 2,173,527 Agayof Sept. 19, 1939 2,298,101 Beal Oct. 6, 1942 2,322,858 Limbert et al June 29, 1943 2,547,758 Keeling Apr. 3, 1951 2,561,569 Flynn July 24, 1951 2,642,874 Keeling lune 23, 1953 2,647,515 Pollock et al Aug. 4, 1953 2,819,718 Goldman Jan. 14, 1958 2,862,497 Pagano Dec. 2, 1958 2,886,035 Loutz May 12, 1959 2,896,629 Warr `luly 28, 1959 2,912,981 Keough Nov. 17, 1959 

1. A SURGICAL TUBE COMPRISING: AN ELONGATED, TUBULAR BODY OF FLEXIBLE, EXTRUDED PLASTIC; A DRAINAGE CHANNEL AND AN INFLATION CHANNEL DEFINED BY THE WALLS OF SAID BODY; A TAPERED, FRUSTO-CONICAL SECTION FLARING OUTWARDLY TOWARD ONE END OF THE BODY; A SECOND FRUSTO-CONICAL SECTION BETWEEN SAID FIRST SECTION AND THE END OF THE BODY, SAID SECOND SECTION FLARING OUTWARDLY AWAY FROM THE END OF THE BODY; A RELATIVELY SHORT CYLINDRICAL SECTION BETWEEN THE TWO FRUSTO-CONICAL SECTIONS, THE DIAMETER AND WALL THICKNESS OF SAID CYLINDRICAL SECTIONS BEING SUBSTANTIALLY THE SAME AS THAT OF THE MAJOR PORTION OF THE BODY; AN ANNULAR SHOULDER AT EACH END OF THE CYLINDRICAL SECTION PROJECTING RADIALLY OUTWARD TO MEET THE BASE OF THE RESPECTIVE FRUSTO-CONICAL SECTION; AND A THIN, RESILIENT, CYLINDRICAL, ELASTIC BALLOON TELESCOPED OVER SAID CYLINDRICAL SECTION. 